FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
130081–130104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1989
MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS
K885175 · DTB
Possis Medical, Inc.
Cardiovascular · 212d
Cleared Jul 14, 1989
BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG
K890096 · FCN
Medical Inventors Corp., Inc.
Gastroenterology & Urology · 185d
Cleared Jul 14, 1989
ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER
K890124 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 184d
Cleared Jul 14, 1989
DISPOSABLE TRANSDUCER MANIFOLD
K890676 · DTL
L.O.N. Research, Inc.
Cardiovascular · 155d
Cleared Jul 14, 1989
OVERDENTURE - STUD ATTACHMENT
K890713 · DZE
Austenal Dental, Inc.
Dental · 151d
Cleared Jul 14, 1989
MYOTEST DBS NERVE STIMULATOR
K890746 · BXN
Biometer Intl. A/S
Anesthesiology · 151d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVES
K890858 · LYY
Rejuvena Ent. Co. , Ltd.
General Hospital · 143d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES (MFG. NINGBO MEDICAL)
K890891 · LYY
Interpro Intl., Inc.
General Hospital · 142d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVE
K890974 · LYY
Barriermed, Inc.
General Hospital · 137d
Cleared Jul 14, 1989
NR LATEX EXAMINATION GLOVES
K891010 · LYY
Universal Bodycare (I) Sdn. Bhd.
General Hospital · 136d
Cleared Jul 14, 1989
SHIELD BRAND (PATIENT EXAMINATION GLOVE)
K891102 · LYY
Poly Shield Industries (Malaysia)...
General Hospital · 134d
Cleared Jul 14, 1989
LATEX PATIENT EXAMINATION GLOVES
K891110 · LYY
I Horng Industrial Co., Ltd.
General Hospital · 134d
Cleared Jul 14, 1989
RUBBERCARE PATIENT EXAMINATION GLOVE
K891123 · LYY
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 134d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891134 · LYY
Grupo Industrial Supertex S.A. DE C.V.
General Hospital · 133d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891174 · LYY
Howard Associates, Inc.
General Hospital · 130d
Cleared Jul 14, 1989
INTERPLEURAL ANESTHESIA KIT W/POLYURETHANE CATH.
K891281 · CAZ
Arrow Intl., Inc.
Anesthesiology · 127d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVES
K891284 · LYY
Real Latex Pvt. , Ltd.
General Hospital · 127d
Cleared Jul 14, 1989
TRACOR RA500 AUDIOMETER
K891373 · EWO
Tracor Instruments Austin, Inc.
Ear, Nose, Throat · 127d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K891379 · LYZ
Lcl Taiwan & Co., Ltd.
General Hospital · 127d
Cleared Jul 14, 1989
EXCELCARE PATIENT EXAMINATION GLOVES
K891500 · LYY
Modern Health Care Products
General Hospital · 120d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891502 · LYY
Rindumas Sdn Bhd
General Hospital · 120d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVES
K891503 · LYY
New Moda Sdn Bhd
General Hospital · 120d
Cleared Jul 14, 1989
NONSTERILE LATEX EXAMINATION GLOVES
K891625 · LYY
World Spring Industries Corp.
General Hospital · 119d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891641 · LYY
Global Latex Products Sdn Bhd
General Hospital · 119d